Actively Recruiting
Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
Led by Chinese PLA General Hospital · Updated on 2026-03-27
120
Participants Needed
6
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
CONDITIONS
Official Title
Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 80 years
- Diagnosed with type 2 diabetes mellitus
- Diagnosed with diabetic kidney disease confirmed by kidney pathology within the past 10 years
- 24-hour urine protein is at least 3.5 grams or urine albumin-to-creatinine ratio is greater than 1000 mg/g
- Estimated glomerular filtration rate (eGFR) is at least 15 ml/min/1.73m²
- Blood pressure controlled at or below 160/100 mmHg
- Glycated hemoglobin (HbA1c) less than 9%
- Willing and able to provide written informed consent
You will not qualify if you...
- Kidney diseases not caused by diabetes mellitus
- Treatment with systemic immunosuppressants within 30 days before enrollment lasting more than one week
- Severe cardiovascular diseases such as congenital heart disease, atrial fibrillation, NYHA class II-IV, or unstable angina
- History of cerebral hemorrhage or infarction within the past six months, except lacunar infarction without residual disorders
- Severe hyperlipidemia with serum triglycerides ≥ 6.2 mmol/L or LDL cholesterol ≥ 4.1 mmol/L
- Hyperkalemia uncontrolled by diet or medication
- Active hepatitis B or C infection exceeding normal virus levels, active tuberculosis, severe immunodeficiency, or HIV infection
- History of malignant tumors within the past five years
- Severe allergy to blood products or heterologous proteins
- Lactating women, women planning pregnancy or egg donation, men or partners planning childbearing or sperm donation without contraception during study and follow-up
- Active infection requiring intravenous antibiotics within one week before enrollment
- Participation in other interventional clinical trials within three months before enrollment
- Any condition deemed unsuitable for the study by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
3
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
4
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
5
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
6
Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
Research Team
X
xiangmei chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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